SenNet Internal Data Use Agreement
For use by and amongst Members of the NIH SenNet Consortium Internal Sharing of Data (“DUA”)
Approved by the SenNet Steering Committee June 15, 2022
TERMS AND DEFINITIONS: SenNet (https://sennetconsortium.org/) is a National Institutes of Health (NIH)-organized and -funded consortium of medical research institutions (“Cellular Senescence Network Program” or “SenNet Program” or “Consortium”). SenNet aims to facilitate research on single cells within tissues by supporting data generation and technology development to explore the relationship between senescent cells and their tissue microenvironment, as well as variability in senescent cell phenotypes at the level of individual cells. Member institutions participating in the Consortium enable groups to effectively collaborate with each other to maximize the chances of overall success of the program. In addition to completing the research goals outlined in their applications, successful applicants will be expected to work collaboratively with all members of the Consortium to contribute to developing SOPs, data and metadata standards, and metrics for data generation; participate in cross-site studies; engage in cross-training; and guide development of data analysis and visualization tools that can be used by the broader scientific community. The program will generate 4D maps of the spatial organization of senescent cells within a variety of organs and tissues in various health states through the integration of imaging and omics assays. The focus of the program is on fresh, fixed, or frozen normal human tissue using a combination of in situ and dissociative assays that can resolve individual cells. There will also be opportunistic incorporation and analysis of circulating cells, biofluids, and of biomedical imaging techniques (MRI, CT, etc.) with the goal of biomarker discovery and validation. These maps will enable and encourage future studies and new insights into inter-individual variation and tissue changes across the lifespan and health/disease continuum. Detailed information on the SenNet Consortium can be found at the SenNet website (https://sennetconsortium.org/). All information shared under this Agreement, including donor Data, results from analyses conducted by sites, maps, etc. shall be considered “Data” for purposes of this Agreement.
SenNet Program members (“SenNet Program Members” or “SenNet Members” or “Members”) include: sites funded through the various SenNet Program grant and other transaction mechanisms (can be found here, https://sennetconsortium.org/involvement/), the National Center for Biotechnology Information (NCBI), NIH, the NIH Common Fund, and other NIH Institutes. Members may be added or removed as SenNet grows and changes over time.
Researchers with a wide range of expertise in senescent cell biology, single cell genomics, proteomics, metabolomics, bioinformatics, statistics, ethics, informatics, and clinical medicine employed by a SenNet Program Member participate in the SenNet network, including: Principal Investigators of the SenNet Tissue Mapping Centers, Technology Development Centers, the CODCC (SenNet Consortium Organization and Data Coordinating Center), and Program Officials from the National Institutes of Health.
Data Sharing Guiding Principles: All Data sharing will adhere to:
1) the terms of consent agreed to by donors/research participants;
2) applicable laws and regulations;
3) the principle that individual SenNet sites within the network have final authority regarding when their site’s Data will be used or shared.
These principles are intended to maximize sharing of all Data generated by the SenNet Members among and between other Members as well as with the wider scientific community, and to do this without compromising Data security or the confidentiality of information about individuals whose Data and/or samples are used for research.
Data Sharing Responsibilities: Whereas Data sharing with entities external to SenNet is governed by the External Data Sharing Policy, all SenNet Data, as defined below in Section 2, can be provided to other Members with or without de-identification under the following provisions:
- Nucleotide sequence level Data, which can be considered identifying, can be freely shared with signatories of this DUA in accordance with the NIH Genomic Data Sharing Policy.
- Data (e.g., images) with personal identifiers (e.g., names, dates of birth, medical record numbers, etc.) can be shared with signatories of this DUA but only for the purposes of stripping of these personal identifiers by Members with expertise in these tasks. Once de-identified, the Data can be freely shared with signatories of this DUA.
In the event that a SenNet Member becomes aware of a breach such that Data (subject to HIPAA / not de-identified) has been inappropriately shared or the subject re-identified, the providing member and the SenNet Network shall be immediately notified via email to all SenNet Member Principal Investigators.
In order to accomplish the scientific goals of the SenNet Program, Principal Investigators of each SenNet award will, in compliance with this DUA, designate Data that meet project requirements and share that Data (the “SenNet Data”) in one or more of the following ways:
(1) distribution to others via dbGaP (https://www.ncbi.nlm.nih.gov/gap/) or a similar secure NIH portal;
(2) distribution to others via SenNet CODCC;
(3) distribution directly among SenNet Program Members.
In the spirit of protecting the privacy and confidentiality of the donor sources, the SenNet Data to be shared within SenNet prior to public release will be provided only to SenNet Program Members that have signed this DUA. In addition, all SenNet Program Members will adhere to NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-Data-sharing/).
All SenNet Program Members may aggregate SenNet Data for different types of analysis from all Member sites. With documented Principal Investigator approval, the SenNet CODCC can submit said SenNet Data to dbGaP and/or other designated Databases administered by the National Institutes of Health. Each SenNet Program Member may share its own Data with external collaborators without approval of the other Members. SenNet Data may be shared by Members with their partner organizations (e.g., organizations that provide site-initiated subcontracted services and/or other services required for SenNet studies), provided that said partner organizations are held to an equivalent standard of confidentiality that applies to Program Members.
Statement of Confidentiality: By signing this Agreement, the authorized official representing a SenNet Program Member, certifies that s/he and the Principal Investigators, fellows, students, and research staff (collectively, “Program Member Representatives”) working on SenNet-related projects on behalf of the SenNet Program Member and represented by such authorized official, are aware of the confidential nature of the research study participant Data maintained by the Member, and of the necessity for maintaining that confidentiality.
The SenNet Member and their Program Member Representatives agree not to attempt to personally identify any SenNet participant or family members based on SenNet Data and agree not to attempt to contact any SenNet participant of a site other than their own. The Member agrees not to transfer or disclose any confidential Data or any information about individual SenNet study participants, except as permitted by this Agreement or as required by law, either during or after the conclusion of the affiliation with SenNet. The Member agrees to provide appropriate security for the SenNet Data, including but not limited to administrative, technical, and physical safeguards intended to prevent unauthorized use or disclosure of such information. In addition, each Member agrees to report in writing to any other Member any use or disclosure of any portion of that Member’s Data of which it becomes aware and that is not permitted by this Agreement, including disclosures that are required by law.
The SenNet Member agrees to ensure that they and their Program Member Representatives do not use, disclose, or transfer any SenNet Data to non-SenNet members except as permitted by this Agreement or as required by law. Further, the Member agrees to return all SenNet Data that has not already been incorporated into analysis to the SenNet CODCC or delete/destroy all printed or electronic SenNet Data of other Members in its possession upon termination of its affiliation with the SenNet Program and to notify the SenNet CODCC when it has done so. A single copy of Data may be kept for the limited purpose of compliance with record retention requirements under law and for research verification.
Limitations of Data Use: The SenNet Member agrees to ensure that Program Member Representatives will only use Data and SenNet Data in a manner that is consistent with any limitations that have been specified for individual studies by the disclosing Member and agreed to by the SenNet Steering Committee and shall ensure compliance with all applicable state and federal laws and regulations governing the use of such Data including the Health Insurance Portability and Accountability Act of 1996 (HIPAA), if applicable, including any and all future amendments.
Liabilities: Each Party shall be responsible for its negligent acts or omissions and the negligent acts or omissions of its employees, officers, or directors, to the extent allowed by law; provided, however, that any Party that is an agency of the United States Government, may be liable only to the extent as provided under the Federal Tort Claims Act (28 U.S.C. Chapter 171). No indemnification for any loss, claim, damage, or liability is intended or provided by any Party under this Agreement.
Limitation: Data and SenNet Data are shared between Members as a service to the research community and to accomplish the objectives of the SenNet Network. They are supplied with no warranties, express or implied, including without limitation, any warranty of merchantability or fitness for a particular purpose or non-infringement. No warranty with respect to the SenNet infrastructure is provided, including without limitation, any uptime warranty. The Parties make no representations that the use of the Study Data will not infringe any patent or proprietary rights of third parties.
This Agreement supersedes and replaces all prior agreements made between SenNet Program Members regarding the sharing and confidentiality of SenNet Data. No modification or waiver of this Agreement shall be valid unless in writing and executed by Member’s authorized official.
For active, central, and accessible documentation, a copy of each SenNet Member’s signatory page to this DUA, of which each is a Party upon signature, will be maintained for reference by SenNet Consortium Organization and Data Coordinating Center provided by the Pittsburgh Supercomputing Center (PSC), Carnegie Mellon University and the University of Pittsburgh (Pitt) on behalf of the SenNet Consortium
DUA SIGNATURE PAGE
By the signature below of a representative or officer who is specifically authorized to execute documents of this type, the institution identified hereby agrees to the terms of this DUA for use by and amongst Members of the NIH SenNet Consortium for Internal Sharing of Data, Final Ver 06/15/2022 without modification.
Agreed to by:
SenNet Member Representative’s Institution
Legal Name of Institution
Address of Institution:
Authorized Signatory (Print Name): _________________________________________________________
Signature: ____________________________________________ Date: ________________
Read & acknowledged by:
SenNet Member Scientific Representative (Print Name): ________________________________________
Signature: ____________________________________________ Date: ________________